Wholesale License (FORM20B, 21B)

Wholesale License Requirements From State Licensing Authority

As per the provisions of the Drugs and Cosmetics Rules, the State Licensing Authority can grant a license for the sale or distribution of drugs in India. The license can be issued under Drugs and Cosmetics Rules to sell, stock, exhibit, or offer for sale or distribute drugs in India. The license can be issued for several products like drugs, biologicals, medical devices, and in-vitro diagnostics.

State Licensing Authority (SLA)is the regulatory authority associated with this service. To obtain this license, an individual is required to apply to the State Licensing Authority. The Competent Authority would then carry out an inspection and then grant a license.

Wholesale License Forms

Form 19/Form 19A:

This form is required to apply for the wholesale license.

Form 20B:

This form grants permission for drugs other than those specified in Schedule C, C (1), and X of Drugs &Cosmetics Act and Rules.

Form 21B:

This form grants permission for the drugs specified in Schedule C & C(1) of the Drugs & Cosmetics Act and Rules.

Important Documents For Wholesale Drug License

To obtain a wholesale license for the sale or distribution of drugs in India, the applicant must submit the following list of documents:

• Layout and area of the facility
• List of directors, proof of ownership
• Proof of ownership, and partnership deed
• Biodata and credentials of the registered pharmacist or competent person
• Invoices for refrigerator and air-conditioning system
• System generated form and affidavits

How To Apply for Wholesale License?

The Wholesale License applicant must follow the following process:

• Creation of login ID on the respective State Licensing Authority website/portal
• Filing of online data on the portal
• Uploading of documents as per the checklist
• Payment of government fee on the portal
• Submission of application on the portal as well as hard copy in the respective State Licensing Authority

Wholesale License Government Fee

For issuing a license, the applicant is required to pay 1500 INR for each license. The applicant must also submit a retention fee after every five years.

Validity of Wholesale License

The license obtained would remain valid lifetime unless the regulatory authority suspends or cancels the license.